RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas

Inclusion Criteria:

* Histologically proven diagnosis of high-grade glioma, including anaplastic glioma (WHO grade III with 1p/19q chromosomes intact), glioblastoma (WHO grade IV) or gliosarcoma (WHO Grade IV);
* The tumor must not have an infratentorial component;
* The patient must have recovered from the effects of surgery, postoperative infection and other complications before enrollment;
* Estimated survival of at least 12 weeks;
* Karnofsky Performance Score of ≥ 70% at the time of entry
* Stable or decreasing steroid dose within 2 weeks of first dose of study drug if patient is taking steroids. No steroid use is also acceptable.
* Neurological stability for at least 14 days prior to first dose of study drug;
* Acceptable liver function at Screening,
* Serum creatinine \< 1.5x institution upper limit of normal
* Acceptable hematologic status at Screening
* Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception.

Exclusion Criteria:

* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
* Recurrent malignant gliomas previously treated with radiotherapy and/or chemotherapy
* Metastases detected below the tentorium or beyond the cranial vault, including tumors with evidence of leptomeningeal metastases as previously indicated;
* Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted;
* Prior radiotherapy to the head or neck (except for T1 glottic cancer), that would result in overlap of radiation fields.
* Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity;
* Unresolved toxicity higher than CTCAE (v. 4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia and hypothyroidism;
* Acquired immune deficiency syndrome (AIDS) due to the potential for increased complications from treatment; note, however, that HIV testing is not required
* No other concurrent chemotherapeutic or investigational agents for this cancer. However, concurrent glucocorticoids are allowed;
* Inability to swallow pills;
* Serious co-morbid medical conditions, or a clinically significant laboratory finding(s) or any finding(s) on history and/or examination that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk;
* Patients who are pregnant or lactating or who are planning to become pregnant during the course of the study are excluded.